Experience

• 

  Medopharm

  Apr 2011 - Jun 2011

  Internship - trainee quality control chemist

  Work profile as QC Chemist includes – Chemical Analysis• Carrying out Sampling Activities, • Carrying Out Raw Material Analysis & Finished Goods Analysis,• Review of Quality Control documents, • Undertake LIMS related activities. • Knowledge on Handling Microbiology Instruments

• 

  St.johns research institute

  Nov 2011 - Jun 2012

  Trainee research coordinator

  Working as: Study Co-ordinator in the following therapeutic area in ImmunologyClinical Trials on Rheumatoid Arthritis -----Phase-II & Phase III- Have completed ICH-GCP training.- Have experience with EDC tools such as:‘idata fax’, ‘OC RDC’, ‘Oracle Clinical’, ‘Inform- PhaseForward’,

• 

  Triesta cro - a hcg group

  Jul 2013 - Feb 2014

  Clinical research coordinator

  - Have experience working on Oncology Clinical Trials- Have experience with EDC tools such as: ‘OC RDC’, ‘Oracle Clinical’, ‘Inform- PhaseForward’,

• 

  Iqvia

  Mar 2014 - Jan 2020

  Have experience working on Start-up, Conduct and Study Close-out activities,Getting exposure in Study start-up activities,Creating Test cases/ Test plan for Listings,Performing of Vendor Reconciliations,Performing of SAE reconciliations,Involved in Vendor Communications for resolution of vendor issues,Assisting and providing clarification to Data reviewer team on day to day study activitiesInvolved in Sponsor meetings,Creating of SAS Listing Specifications,Assisting SAS programmers in programming activities,Interacting with other study teams(Clinicals, SAS programmers, QCode programmers, Codingteams,CRA) to support, set-up, management and closure of DM issues.Involved in Mentoring New study resources on the study activities,Performing Data Transfer validations,Creating study status report for all the studiesInvolved in performing Quality checks on regular intervals for maintaining query and listing quality Show less Worked as a Data Operations Coordinator on Conduct and Closeout activities, Have experience in Discrepancy management, Listing review, Edit check creation, Test plan creation, Performing QC activitiesHave expertise in both Rave and Inform database platform.Have experience working on Conduct and Study Close-out activities,Query management and resolution,SAS Listings review,Performing of Vendor Reconciliations,Performing of SAE reconciliations,Involved in Internal study meetings,Management and resolution of issues based on communication logs(DRM & BIOS)Creating Test plans and performing data entry in QC environment, Show less

  • Sr. Clinical Data Co-ordinator

    Oct 2018 - Jan 2020

  • Clinical Data Coordinator

    Mar 2016 - Sept 2018

  • Associate Clinical Data Coordinator

    Mar 2014 - Mar 2016
• 

  Covance

  Jan 2020 - Feb 2022

  Clinical data lead

  Working as a Study Lead on 2 different projectsMentoring and providing training the study team on different study requirementsPlanning study activities with the team as per the timelinesInteracting and communicating with the Sponsor about the study statusCommunicating with sponsor about the upcoming challenges and potential discrepanciesInteracting with the multiple stakeholders about outstanding or pending issuesAssisting the Study Team on timely completion of different planned and ad-hoc activities during stringent study timelinesHave contributed in Spec update and UAT for programming of SAS checks Have involved in UAT (or) Validation activities during study start-upTimely follow-up with the Study Team over clarification and resolution of outstanding study issuesAssisting Study Team in performing day to day study activities such as Queries, SAS & Manual Listings review, SAE & Vendor Reconciliations, Maintaining Issue logs etc.Involved in performing QC on timely basis for all study activities and re-training the study team whenever required Show less

• 

  Atorus

  Mar 2022 - now

  • Principal Clinical Data Manager

    Apr 2024 - now

  • Lead Clinical Data Manager

    Mar 2022 - Mar 2024